Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Arm A (Combination Chemotherapy)

Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm B (Combination Chemotherapy)

Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm C (Combination Chemotherapy)

Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm D (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

cetuximab: Given IV

Arm E (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

leucovorin calcium: Given IV

fluorouracil: Given I

cetuximab: Given IV

Arm F (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab as in arm D and chemotherapy as in arm C.

irinotecan hydrochloride: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

cetuximab: Given IV

Arm G (Locally Directed Therapy)

Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.

Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Arm A (Combination Chemotherapy)

Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm B (Combination Chemotherapy)

Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm C (Combination Chemotherapy)

Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

Arm D (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

cetuximab: Given IV

Arm E (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.

irinotecan hydrochloride: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

cetuximab: Given IV

Arm F (Combination Chemotherapy, Monoclonal Antibody)

Patients received cetuximab as in arm D and chemotherapy as in arm C.

irinotecan hydrochloride: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV

cetuximab: Given IV

Arm G (Locally Directed Therapy)

Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.

Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.

Total

Total of all reporting groups

Baseline Measures

Arm A (Combination Chemotherapy)

Arm B (Combination Chemotherapy)

Arm C (Combination Chemotherapy)

Arm D (Combination Chemotherapy, Monoclonal Antibody)

Arm E (Combination Chemotherapy, Monoclonal Antibody)

Arm F (Combination Chemotherapy, Monoclonal Antibody)

Arm G (Locally Directed Therapy)

Total

Number of Participants
[units: participants]

1402

111

111

1350

45

46

332

3397

Age
[units: years]Median ( Full Range )

58
( 19 to 85 )

57
( 25 to 82 )

60
( 24 to 82 )

58
( 22 to 86 )

59
( 30 to 82 )

60.5
( 30 to 81 )

56
( 22 to 84 )

58
( 19 to 86 )

Gender
[units: participants]

Female

662

53

50

647

20

21

160

1613

Male

740

58

61

703

25

25

172

1784

Ethnicity (NIH/OMB)
[units: participants]

Hispanic or Latino

64

5

3

62

4

2

18

158

Not Hispanic or Latino

1107

103

103

1060

38

41

225

2677

Unknown or Not Reported

231

3

5

228

3

3

89

562

Race (NIH/OMB)
[units: participants]

American Indian or Alaska Native

6

1

1

7

0

0

1

16

Asian

66

4

2

62

3

0

12

149

Native Hawaiian or Other Pacific Islander

8

0

1

7

0

0

0

16

Black or African American

94

6

7

96

5

2

29

239

White

1202

98

100

1154

37

43

275

2909

More than one race

3

2

0

3

0

0

1

9

Unknown or Not Reported

23

0

0

21

0

1

14

59

Region of Enrollment
[units: participants]

United States

1258

109

109

1224

44

46

303

3093

Canada

138

2

2

124

1

0

28

295

Jamaica

1

0

0

0

0

0

0

1

Puerto Rico

5

0

0

2

0

0

1

8

Positive Nodes
[1][units: participants]

1-3

816

71

70

790

29

28

203

2007

4+

586

40

41

560

16

18

129

1390

Tumor Stage
[2][units: participants]

T1 or T2

198

18

14

213

5

5

56

509

T3

1046

78

93

983

35

39

214

2488

T4

158

15

4

153

4

2

62

398

Not Availabe

0

0

0

1

1

0

0

2

Histologic Grade
[3][units: participants]

High

357

25

28

345

10

12

60

837

Low

1045

86

83

1005

35

34

272

2560

KRAS Status
[units: participants]

Unknown

56

6

6

51

3

4

6

132

Mutant

391

33

43

345

15

13

326

1166

Wildtype

955

72

62

954

27

29

0

2099

[1]

Number of positive nodes

[2]

T1: Tumor invades submucosa

T2: Tumor invades muscularis propria

T3: Tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues

T4: (T4a+) Tumor perforates the visceral peritoneum without adherence to or invasion of other organs or structures or (T4b) Tumor is adherent to or directly invades other organs or structures

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Accrual to arms A and D terminated early based on the results of the planned 2nd interim analysis. Sample sizes limit statistical conclusions for data from the irinotecan treated patients as those treatment arms were discontinued early in the study.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.